Patient leaflet - Donepezil Hydrochloride 5 mg orodispersible tablets
1. What Donepezil hydrochloride is and what it is used for
This medicine contains the active substance donepezil hydrochloride. This medicine belongs to a group of medicines called acetylcholinesterase inhibitors. Donepezil increases the levels of a substance (acetylcholine) in the brain involved in memory function by slowing down the breakdown of acetylcholine.
It is used to treat the symptoms of dementia in people diagnosed as
having mild and moderately severe Alzheimer's disease. The symptoms include increasing memory loss, confusion and behavioural changes. As a result, sufferers of Alzheimer's disease find it more and more difficult to carry out their normal daily activities.
Donepezil hydrochloride is for use in adult patients only.
2. What you need to know before you take Donepezil hydrochloride Do not take Donepezil hydrochloride
Ÿ If you are allergic to donepezil hydrochloride, or to piperidine
derivatives, or any of the other ingredients of this medicine (listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Donepezil hydrochloride if you have or have had:
Ÿ stomach or duodenal ulcers
certain abnormal heart rhythms called Torsade de Pointes or if anyone in your family has 'prolonged QT interval' Ÿ seizures (fits) or convulsions
Ÿ a heart condition (such as irregular or very slow heart beat, heart
failure, myocardial infarction )
Ÿ a heart condition called 'prolonged QT interval' or a history of
Ÿ low levels of magnesium or potassium in your blood
Ÿ asthma or other long term lung disease
Ÿ liver problems or hepatitis
Ÿ difficulty passing urine or mild kidney disease
Also tell your doctor if you are pregnant or think you might be pregnant.
Donepezil hydrochloride can be used in patients with kidney disease or mild to moderate liver disease. Tell your doctor first if you have kidney or liver disease. Patients with severe liver disease should not take Donepezil hydrochloride.
Tell your doctor or pharmacist the name of your caregiver. Your caregiver will help you to take your medicine as it is prescribed.
Children and adolescents
This medicine is not recommended for use in children and adolescents (younger than 18 years of age).
Other medicines and Donepezil hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
This includes medicines that your doctor has not prescribed for you but which you have bought yourself from a chemist/pharmacist. It also applies to medicines you may take some time in the future if you continue to take Donepezil hydrochloride. This is because these medicines may weaken or strengthen the effects of Donepezil hydrochloride.
Ÿ medicines for heart rhythm problems e.g. amiodarone, sotalol Ÿ medicines for psychosis e.g. pimozide, sertindole, ziprasidone In particular it is important to tell your doctor if you are taking any of the following types of medicines:
Ÿ other Alzheimer's disease medicines, e.g. galantamine Ÿ pain killers or for treatment of arthritis e.g. aspirin, non-steroidal anti-inflammatory (NSAID) drugs such as ibuprofen or diclofenac sodium
Ÿ anticholinergics medicines, e.g. tolterodine
Ÿ medicines for bacterial infections e.g. clarithromycin, erythromycin, levofloxacin, moxifloxacin, rifampicin Ÿ anti-fungal medicine e.g. ketoconazole
Ÿ medicines for depression e.g. citalopram, escitalopram, amitriptyline fluoxetine
Ÿ anticonvulsants e.g. phenytoin, carbamazepine
Initially, the recommended dose is 5 mg (one white tablet) every night before you go to bed. After one month, your doctor may tell you to take 10 mg (one yellow tablet) every night before you go to bed. Ÿ medication for a heart condition e.g. quinidine, beta-blockers
(propranolol and atenolol)
Ÿ muscle relaxants e.g. diazepam, succinylcholine
Ÿ general anaesthetic
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Ÿ medicines obtained without a prescription e.g. herbal remedies
Food will not influence the effect of Donepezil hydrochloride. If you are going to have an operation that requires you to have a general anaesthetic, you should tell your doctor and the anaesthetist that you are taking Donepezil hydrochloride. This is because your medicine may affect the amount of anaesthetic needed.
Donepezil hydrochloride with food, drink and alcohol
Do not take this medicine with alcohol because alcohol may change its effect.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should not take Donepezil hydrochloride
while breast-feeding.
Driving and using machines
Alzheimer's disease may impair your ability to
drive or operate machinery and you must not perform these activities unless your doctor tells you that it is safe to do so.
Also, your medicine can cause tiredness, dizziness and muscle cramp. If you experience any of these effects you must not drive or operate machinery.
3. How to take Donepezil hydrochloride
How much Donepezil hydrochloride should you take
Recommended dose
If you experience abnormal dreams, nightmares or difficulty in sleeping (see section 4) your doctor may advise you to take Donepezil hydrochloride in the morning.
The tablet strength you will take may change depending on the length of time you have been taking the medicine and on what your doctor recommends.
The maximum recommended dose is 10 mg each night.
Always follow your doctor or pharmacist's advice about how and when to take your medicine. Do not alter the dose yourself without your doctor's advice.
How to take your medicine
Place the tablet on your tongue and allow it to disintegrate before swallowing, with or without water, according to your preference.
Use in Children and adolescents
Donepezil hydrochloride is not recommended for use in children and adolescents (younger than 18 years of age).
For how long should you take Donepezil hydrochloride
Your doctor or pharmacist will advise you on how long you should continue to take your tablets. You will need to see your doctor from time to time to review your treatment and assess your symptoms.
If you take more Donepezil hydrochloride than you should
Contact your doctor or the nearest hospital emergency department immediately if you take more of the medicine than you should. Take this leaflet and any remaining tablets with you.
Overdose symptoms may include nausea (feeling sick) and vomiting (being sick), drooling, sweating, slow heart rate, low blood pressure (light-headedness or dizziness when standing), breathing problems, losing consciousness and seizures (fits) or convulsions.
If you forget to take Donepezil hydrochloride
If you forget to take your medicine, take the next dose at the usual time. Do not take a double dose to make up for a forgotten tablet. If you forget to take your medicine for more than one week, call your doctor before taking any more medicine.
If you stop taking Donepezil hydrochloride
Do not stop taking the tablets unless told to do so by your doctor. If you stop taking Donepezil hydrochloride, the benefits of your treatment will gradually fade away.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported by people taking Donepezil hydrochloride.
Tell your doctor if you have any of these effects while you are taking this medicine.
Serious side effects:
You must tell your doctor immediately if you notice these serious side effects mentioned.
You may need urgent medical treatment.
Ÿ liver damage e.g.hepatitis. The symptoms of
hepatitis are nausea (feeling sick) or vomiting (being sick), loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine (may affect up to 1 in 1,000 people).
Ÿ stomach or duodenal ulcers. The symptoms of ulcers are stomach
pain and discomfort (indigestion) felt between the navel and the breast bone (may affect up to 1 in 100 people).
Ÿ hallucinations (seeing or hearing things that are not really there) Ÿ bleeding in the stomach or intestines. This may cause you to pass
black tar like stools or visible blood from the rectum (may affect up to 1 in 100 people).
consciousness (a disorder called “Neuroleptic Malignant Syndrome”) (may affect up to 1 in 10,000 people) Ÿ seizures (fits) or convulsions (may affect up to 1 in 100 people)
Ÿ fever with muscle stiffness, sweating or a lowered level of
Ÿ muscle weakness, tenderness or pain and particularly, if at the
same time, you feel unwell, have a high temperature or have dark urine. They may be caused by an abnormal muscle breakdown which can be life threatening and lead to kidney problems (a condition called rhabdomyolysis) (may affect up to 1 in 10,000 people)
Ÿ fast, irregular heart beat and fainting, which could be symptoms of
a life-threatening condition known as Torsade de Pointes (frequency cannot be estimated from the available data)
Other side effects
Very common side effects (may affect more than 1 in 10 people): Ÿ diarrhoea
Ÿ headache
Common side effects (may affect up to 1 in 10 people):
Ÿ muscle cramp
Ÿ tiredness
Ÿ difficulty in sleeping (insomnia)
Ÿ the common cold
Ÿ unusual dreams including nightmares
Ÿ agitation
Ÿ aggressive behaviour
Ÿ fainting
Ÿ dizziness
Ÿ stomach feeling uncomfortable
Ÿ rash
Ÿ passing urine uncontrollably
Ÿ accidents (patients may be more prone to falls and accidental injury) Ÿ pain
Uncommon side effects (may affect up to 1 in 100 people): Ÿ slow heart beat
Ÿ salivary hypersecretion
Rare side effects (may affect up to 1 in 1000 people): Ÿ stiffness, shaking or uncontrollable movement especially of the face and tongue but also of the limbs
Not Known (frequency cannot be estimated from the available data): Ÿ Changes in the heart activity which can be seen on an electro-cardiogram (ECG) called 'prolonged QT interval' Ÿ libido increased, hypersexuality
Ÿ Pisa syndrome (a condition involving involuntary muscle contraction with abnormal bending of the body and head to one side)
Reporting of side effects
Keep this medicine out of the sight and reach of children. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Donepezil hydrochloride
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.
Donepezil hydrochloride 5 mg orodispersible tablets: White to off-white colour, circular, flat face bevelled edge uncoated tablet debossed with “CL 31” on one side and plain on the other side. Do not store above 30°C
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Donepezil hydrochloride contains
sodium chloride, ferric oxide yellow and magnesium stearate. Ÿ The active substance is donepezil
hydrochloride. Two different strengths of
tablets are available. Each 5 mg
orodispersible tablet contains 5 mg of
donepezil hydrochloride and each 10 mg
orodispersible tablet contains 10 mg of donepezil hydrochloride.
Ÿ The other ingredients are mannitol, crospovidone, sucralose,
What Donepezil hydrochloride looks like and contents of the pack
Donepezil hydrochloride 10 mg orodispersible tablets: Yellow colour, circular, flat face bevelled edge uncoated tablet debossed with “CL 32” on one side and plain on the other side.
Blister pack comprises of Aluminium foil and cold form laminate. Pack sizes: 14 and 28 orodispersible tablets in blister packs.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Macleods Pharma UK Limited.
Wynyard Park House, Wynyard Avenue,
Wynyard, Billingham, TS22 5TB,
United Kingdom.
PL 34771/0280-0281